Senior Manager, GxP Controlled Document Management (m/f/d)

Responsibilities

1. Management and administration of the global GxP Policies, Standard Operating Procedures (SOPs) and Working Practices (WPs).

2. Cover GxP documents related to Medical Affairs, Regulatory Affairs, IT, and others if needed.

3. Independently coordinate the development and revision of these documents, following the Global Procedure for document management.

4. Create project plan and maintain timelines, drive revisions to completion.

5. Provide oversight and guidance for Key Stakeholders of SOPs.

6. Maintain current records in the electronic Document Management System (eDMS).

7. Liaise with the Global Training Group.

8. Support the management of deviations and CAPAs related to GxP Document Management.

9. Participate in internal improvement projects, lead projects as assigned.

Minimum Requirements

1. Education in natural science or equivalent number of years’ experience.

2. At least 5 years of pharmaceutical or medical device industry experience, preferably including Quality Management for GxPs.

3. Expert knowledge and experience in relevant regulations and guidance documents, e.g. in the area of Clinical Development, Medical Devices, IMP management, Regulatory Affairs or Pharmacovigilance.

4. Strong expertise with MS Word and MS Teams, including managing teams and channels.

5. Working expertise with MS PowerPoint and Visio.

6. eDMS and project management software knowledge preferred, e.g. Veeva QualityDocs, Monday.com.

7. Project Management experience, ability to work with stakeholders across time zones.

8. Excellent communication skills in English, written and spoken, ability to explain processes and to guide internal customers on different hierarchy levels and from different countries.

9. Accustomed to working independently, with a high degree of accuracy, and the ability to be flexible and adaptive to change.

10. Strong problem management skills; using analytical and creative thinking.

11. Ability to come to the office 2 days a week during the onboarding, and once per month after that.

12. Japanese language skills would be a bonus.

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